Observational Study of Rebismart®2.0 + MSdialog™ in Subjects With Remitting Multiple Sclerosis (ADHERQOL)

Merck KGaA (EMD Serono)

Status: Terminated

Conditions: Multiple Sclerosis, Relapsing-remitting

Treatments: Device: MSdialog™; Device: RebiSmart®2.0

Study type: Observational

Funder types: Industry

Identifiers

NCT02394782

EMR200136-591

Details and patient eligibility

About

This is a 24-month, observational, prospective, multinational, multicenter study to determine the relationship between the relapse (percentage of relapse free subjects) and adherence in subjects diagnosed with RRMS treated with Rebif (interferon beta-1a) using the RebiSmart®2.0 and MSdialog™.

Enrollment: 8 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with RRMS according to McDonald criteria 2010
• Relapse free within 30 days before Baseline data collection
• Treatment with Rebif for 6 months or more prior to informed consent
• Already using RebiSmart®2.0 + MSdialog™ for patient reported outcome (PRO) assessments (at least once prior to informed consent)
• Females of childbearing potential must be willing to use appropriate contraception for the duration of the study
• EDSS score less than (<) 6
• Written informed consent obtained prior to any protocol-required data collection

Exclusion criteria

• Participation in other studies within 30 days before Baseline
• Female who is pregnant or breast feeding
• Significant psychiatric symptoms that, in the opinion of the Investigator, would impact subject ability to comply with treatment (as per standard clinical practice)
• Any contraindication for Interferon (IFN) beta-1a therapy as per Summary of Product Characteristics (SPC)
• Administration of any Multiple Sclerosis (MS) therapy, other than Rebif, within 6 months prior to informed consent

Trial design

8 participants in 1 patient group

Relapsing-remitting Multiple Sclerosis

Treatment:

Device: MSdialog™

Device: RebiSmart®2.0